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Parkinson's DiseasePDvsCOPDNCT02098577

Crossover Versus Stabilometric Platform in Parkinson's Disease

An observational study of Parkinson's Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Crossover and Stabilometric Platform
How many people
60 participants
Where
1 siteItaly
Study dates
Jun 2013to Feb 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 60 patients with PD in stage III Hoen\&Yahr according to Gelb et la. with the ability to walk without any assistance and with Mini Mental State Examination (MMSE) score > 26.

Who may be able to join

  • PD in stage III Hoen\&Yahr according to Gelb et la. with the ability to walk without any assistance and with Mini Mental State Examination (MMSE) score > 26

Who cannot join

  • MMSE < 26
  • Coexistence of other neurological diseases
  • PD patients with relevant orthopedic, rheumatic and muscular conditions

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedale generale di zona "Moriggia-Pelascini"

    Gravedona, Como, 22015

Other trials in Italy

About this study

Official title: Effect of Two Different Rehabilitation Programs on Balance in Parkinsonian Patients: Crossover Versus Stabilometric Platform

The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform.

Read the detailed description

Parkinson's disease (PD) is a neurodegenerative disorder characterized by different motor symptoms (rigidity, akinesia, tremor and impairment of balance and gait). Even though pharmacological treatment has changed the natural course of the disease, balance worsens over time and leads to falls. The aims of this study is to assess the efficacy of the crossover (group 1) on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform (group 2). The group 1 executed 6 days/week for a 4-weeks cycle a crossover protocol based on the first 4 level of resistance and a training which lasts at most 5 minutes. The group 2 executed 6 days/week for a 4-weeks cycle different exercises with the stabilometric platform in monopodalic and in bipodalic standing.

Being tested
Crossover, Stabilometric Platform
Keywords
Balance
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CrossoverOther

    Crossover cycle

  • Stabilometric PlatformOther

    This Stabilometric plate allows to assess the balance with an objective and reliable measurement, in both standard static or dynamic unstable condition

Study groups in NCT02098577
Study groupRoleWhat they receive
PD patients cross-over treatment30 PD patients (according to Gelb et al) in Hoen\&Yahr stage 3, underwent cross-over treatment with the ability to walk without any assistance with mini-mental state examination score >26.
Receives: Other: Crossover
PD patients stabilometric platform30 PD patients (according to Gelb et al) in Hoen\&Yahr stage 3, underwent stabilometric platform treatment, with the ability to walk without any assistance with mini-mental state examination score >26.
Receives: Other: Stabilometric Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BBS

    Berg Balance Scale

    Measured: One month

Secondary outcomes (4)

  1. 6MWT

    Six minutes walking test

    Measured: One month

  2. TUG

    Time up and Go test

    Measured: One month

  3. UPDRS II

    Unified Parkinson's disease Rating Scale II

    Measured: One month

  4. UPDRS III

    Unified Parkinson's disease Rating Scale III

    Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02098577
Sponsor's protocol ID
PDvsCOPD
Other IDs
PDvsCOPD
Acronym
PDvsCOPD
Status last verified
Mar 2014
First submitted
22 Mar 2014
Last updated
28 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BBS (time frame: One month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02098577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014; AzTrials last refreshed its copy on 27 Oct 2026.

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